Fluid Loss
Conditions
Brief summary
The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.
Interventions
DEVICECM-1500
The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.
DEVICECM-1600
The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value.
Sponsors
Zynex Monitoring Solutions
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide written informed consent * Ability and willingness to comply with the study procedures and duration requirements * 18 years of age or older * Consented to undergo an apheresis procedure with an automated blood component device
Exclusion criteria
* Females who are pregnant or breastfeeding * Undergone an amputation of the left upper extremity * Diagnosed with dextrocardia * Subjects who have a pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize Changes in the Relative Index During an Apheresis Procedure | Duration of apheresis procedure (e.g., 2 - 3hrs) | The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Apheresis Platelet Donation: CM-1500 The subjects will be connected to the CM-1500 during apheresis platelet donation
CM-1500: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value. | 46 |
| Apheresis Platelet Donation: CM-1600 The subjects will be connected to the CM-1600 during apheresis platelet donation
CM-1600: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value. | 31 |
| Total | 77 |
Baseline characteristics
| Characteristic | Apheresis Platelet Donation: CM-1600 | Total | Apheresis Platelet Donation: CM-1500 |
|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 12.5 | 50.7 years STANDARD_DEVIATION 16.5 | 47.3 years STANDARD_DEVIATION 17.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 31 participants | 77 participants | 46 participants |
| Sex: Female, Male Female | 15 Participants | 40 Participants | 25 Participants |
| Sex: Female, Male Male | 16 Participants | 37 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 31 |
| other Total, other adverse events | 1 / 46 | 1 / 31 |
| serious Total, serious adverse events | 0 / 46 | 0 / 31 |
Outcome results
Primary
Characterize Changes in the Relative Index During an Apheresis Procedure
The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.
Time frame: Duration of apheresis procedure (e.g., 2 - 3hrs)
Population: 4 subjects were withdrawn from the CM-1500 Arm, and 3 subjects were withdrawn from the CM-1600 Arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Apheresis Platelet Donation: CM-1500 | Characterize Changes in the Relative Index During an Apheresis Procedure | 94.9 Relative Index | Standard Deviation 5.6 |
| Apheresis Platelet Donation: CM-1600 | Characterize Changes in the Relative Index During an Apheresis Procedure | 99.3 Relative Index | Standard Deviation 26.3 |